Regulatory Partner @ Roche

3 days ago

Warszawa, Czech Republic Roche Full time

Who you are:

  • Higher medical, pharmaceutical, or related education.
  • At least 3 years of experience in the pharmaceutical industry.
  • English and Polish proficiency.
  • Possesses knowledge regarding GxP (GVP, GCP) and uses it during daily activities.
  • Proficient in medical and registration terminology and understands the medicinal product lifecycle.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Regulatory Partner

At Roche, our mission is to deliver innovative medicines and services that truly make a difference for patients. This senior-level opportunity as a Regulatory Partner puts you at the heart of that mission, where you will implement registration strategies through hands-on operational work, ensure compliance while supporting patient access to the newest therapies and beyond-the-product services, and contribute your expertise to inform business strategy with up-to-date regulatory insights and guidance for smooth product or device launches. You will also coordinate, supervise, and drive initiatives within your area of responsibility, making a tangible impact on both projects and patient outcomes.

We offer a hybrid work model that combines flexibility with in-person collaboration. For now, we require our employees to be in our office in Warsaw on average two days per week. The specific office days may vary depending on business needs, such as workshops, conferences, town halls, team meetings, and other collaborative events.

What you get:

  • Competitive salary  based on the employment contract (Umowa o pracę),
  • Annual bonus payment based on your performance.
  • Dedicated training budget (training, certifications, conferences, diversified career paths etc.).
  • Recharge Fridays (2 Fridays off per quarter available).
  • Take time Program (up to 3 months of leave to use for any purpose).
  • Vacation subsidy available.
  • Flex Location (possibility to perform our work from different places in the world for a certain period of time).
  • Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).
  • Private healthcare (LuxMed packages), group life insurance (UNUM) and Multisport.
  • Stock share purchase additions.
  • Yearly sales of company laptops and cars and many more
,[Work with the global team to secure new Marketing Authorizations locally and fulfill all obligations of the Marketing Authorization Holder and/or its affiliate after authorization, in line with pharmaceutical law and internal procedures (local and global)., Build and maintain strong relationships with key institutions – URPL, GIF, MZ, and industry associations such as INFARMA – to influence registration processes, support early advocacy, co-create industry solutions, and shape the regulatory environment., Ensure doctors, pharmacists, and patients receive the information needed for safe medicine use (e.g., Risk Management Plan, DHPC letters)., Review promotional and informational materials for compliance, manage the abbreviated Summary of Product Characteristics., Provide stakeholders with timely regulatory updates and intelligence to support activity prioritization, product development, clinical trials, documentation needs, and awareness of major regulatory changes., Secure audit readiness by applying the “right first time” principle across all audited activities., Manage registration documentation: ensure proper circulation, timely submission to authorities, and systematic archiving.] Requirements: GXP, GCP Additionally: Annual bonus, Private healthcare, Training budget, Conference budget, Work-life balance, Sport subscription, Recharge Fridays, Take time Program, International projects, Gym, Canteen, Bike parking, Playroom, Free parking, In-house trainings, No dress code, Modern office.

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